Biopharmaceutical giant Amgen has filed a claim with the US International Trade Commission requesting for a ban on imports of an experimental anemia drug called Cera, manufactured by Roche. According to Amgen, Roche’s manufacturing protocol infringes Amgen’s patents covering its own anemia drug, Epogen. Roche denies this, arguing that
its pegylated version of EPO does not infringe Amgen’s patents because it is linked to a chemical that makes it last longer in the body than Epogen, which Amgen sells in the United States as a treatment for anemia in patients on kidney dialysis.
According to a Reuters article, Roche’s Cera has not yet been approved for sale in the US or in Europe. Amgen is hopeful that the ITC will launch a formal investigation which might take months to complete, considering that Amgen is seeking a “permanent exclusion order.” Meanwhile, Roche will continue to file marketing applications worldwide.